Chr t(11;14)

P1/2, N=27, Recruiting, OHSU Knight Cancer Institute | Not yet recruiting --> Recruiting

P1/2, N=54, Terminated, Incyte Corporation | Completed --> Terminated; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.

Serial assessments were performed before and during treatment with bortezomib and dexamethasone for MM, and later with daunorubicin/cytarabine for AML. It demonstrates the earliest events in pDC-AML evolution. Furthermore, the immature immunophenotype raises the question of appropriate treatment, since a diagnosis of acute undifferentiated leukemia can be established.

Venetoclax combination regimen achieved excellent efficacy and safety in the treatment of relapsed/refractory multiple myeloma with t(11;14) in this case. The treatment of patients with relapsed and refractory multiple myeloma with t(11;14) by venetoclax still needs to be confirmed by more clinical studies.

P2, N=39, Not yet recruiting, Peking University People's Hospital

Our findings confirm the aggressive clinical course and poor prognosis of these disease manifestations, mainly when they occur at relapse. In the absence of standardized treatment guidelines, individualizing therapy and accessing novel strategies may be essential for improving patient survival.

P1, N=24, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting

However, the need for longer follow-up and expanded cohorts remains critical to validate these outcomes and optimize patient selection. These findings support the further exploration of venetoclax and azacitidine as a viable treatment option for patients with refractory or high-risk multiple myeloma, warranting additional prospective trials before consideration for standard-of-care implementation.

P3, N=466, Not yet recruiting, Alliance for Clinical Trials in Oncology

P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2025 --> Oct 2026

In 10 patients with paired, pre- and post-venetoclax treatment samples, post-venetoclax progression was recurrently driven by the selection of genomic events in BCL2/MCL1 and RAS pathways and of high-risk features (e.g., loss of TP53 and CDKN2C). Overall, our study shows that comprehensive genomic profiling can identify most mechanisms underlying resistance to BCL2 inhibition in t(11;14)(CCND1;IGH) MM.

Venetoclax (VEN), a BCL2 inhibitor, has been used in combination with Azacitidine in acute myeloid leukemia, in the trial setting in high-risk myelodysplastic syndrome (MDS), and in t(11; 14) MM in the salvage setting...Following diagnosis with IgG t(11; 14) MM, the patient received treatment with Lenalidomide, Bortezomib, and Dexamethasone and achieved a very good partial response...Bone marrow biopsy demonstrated response from the perspective of both malignancies, until she had relapsed disease with a mixed phenotype acute leukemia ∼ 19 months after relapsed MM/diagnosis of high-risk MDS. Overall, this case demonstrates successful treatment of both hematologic malignancies at a lower dose of VEN than previously shown to be efficacious in t(11; 14) MM.